• 2nd Setting Specifications
    for Biological Products:
    A Pathway to Harmonization

    December 2-3, 2019
    US Pharmacopeia - Rockville, Maryland
    IABS
  • Meeting organized by
    » IABS

Meeting documents & Info

Presentations

About the Meeting

Objectives of the meeting

This 2nd meeting will expand on considerations discussed in a September 2013 workshop and include participants from biotechnology medicinal products, vaccines, and gene & cell therapies. The goals of this workshop will be to explore the implications from lack of worldwide agreement on principles and practices in setting product specifications and discuss a pathway towards harmonization. Business and regulatory strategies for managing worldwide specifications will be reviewed and challenged. Data sources and statistical approaches for setting limits which reflect product quality will be discussed. The meeting will bring the right experts together to discuss the issues and through roundtables attempt to reach conclusions that will be valuable globally to public health.

Scientific committee

Shawn Novick
International Alliance for Biological Standardzation
Kris Barnthouse
Johnson and Johnson
Barry Cherney
Food and Drug Administration
Fiona Cornel
Health Canada
Melody Gossage
Eli Lilly and Company
Kristi Griffiths
Eli Lilly and Company
Brendan Hughes
Bristol-Myers Squibb
Robin Levis
Food and Drug Administration
Yunsong Li
Catalent
Anthony Lubinieki
International Alliance for Biological Standardzation
John McKnight
AstraZeneca
Ned.m.Mozier
Pfizer
Laura Pack
Seattle Genetics
Tim Schofield
International Alliance for Biological Standardzation
Meiyu Shen
Food and Drug Administration
Dean Smith
Health Canada
Vic Vinci
Catalent
Mats Welin
Medical Products Agency Sweden